Quality Assurance Manager - Cell & Gene Therapy
Core
Develop, implement, and oversee the Quality Management System (QMS) for Cell and Gene Therapy (CGT) collection services, ensuring compliance with FDA regulations and industry standards.
Role type
Quality Assurance Manager
Builds
Centralized QMS covering donor eligibility, informed consent, apheresis/cell-collection processes, labeling, and packaging workflows
Domain
Healthcare / Cell & Gene Therapy / Regulatory Compliance
Required skills
QMS development and implementation, FDA 21 CFR 1271/210/211 compliance, FACT-JACIE and AABB standards knowledge, audit management, CAPA management, vendor and supply management, electronic QMS (eQMS) proficiency, regulatory submission preparation (510(k), PMA, EU MDR), cross-functional team leadership
Preferred skills
Experience in apheresis, blood banking, or GMP/GTP environments, strategic roadmap development for medical devices
Technologies
eQMS platforms, MS Office suite
Responsibilities
Build and manage a fully compliant, centralized QMS; Ensure compliance with FDA and industry standards; Oversee process mapping and creation of SOPs; Lead quality risk management initiatives; Ensure robust Chain of Identity and Chain of Custody systems; Oversee training and competency management programs; Define quality metrics, KPIs, and dashboards; Lead end-to-end preparation of global regulatory submissions
Seniority
Manager, hands-on leadership
